ARD Online First, published on July 13, 2012 as 10.1136/annrheumdis-2012-201456 Clinical and epidemiological research
EXTENDED REPORT
Very early rheumatoid arthritis as a predictor of remission: a multicentre real life prospective study Elisa Gremese,1 Fausto Salaffi,2 Silvia Laura Bosello,1 Alessandro Ciapetti,2 Francesca Bobbio-Pallavicini,3 Roberto Caporali,3 Gianfranco Ferraccioli1 1
Rheumatology Division, Catholic University of the Sacred Heart, Rome, Italy 2 Rheumatology Department, Università Politecnica delle Marche, Ancona, Italy 3 Rheumatic Disease Unit, School of Medicine, Policlinico San Matteo, Pavia, Italy Correspondence to Professor Gianfranco Ferraccioli, Institute of Rheumatology and Affine Sciences, School of Medicine, Catholic University of the Sacred Heart, CIC-Via Moscati 31, Rome 00168, Italy;
[email protected] Received 2 February 2012 Accepted 20 May 2012
ABSTRACT Background To assess whether, in the real world of three early arthritis clinics, early referral could allow the best outcome, ie, remission, to be reached, and whether reaching the outcome was more dependent on therapy than on disease duration or vice versa. Methods 1795 patients with early arthritis (symptom duration ≤12 months) were entered into a prospective follow-up study. 711 patients (39.6%) were diagnosed with rheumatoid arthritis (RA). Each RA patient was treated according to the local algorithm, in three tertiary referral centres (representing a small province, a medium sized province and a metropolitan area, respectively). Remission, defined using the disease activity score in 28 joints (DAS28 3.2), in order to highlight more stringent results. Clinical (DAS28, health assessment questionnaire; HAQ) as well as laboratory (acute phase reactants, IgM-rheumatoid factor, anticitrullinated protein autoantibodies; ACPA) data were collected over time. Seropositivity was defined as previously described.9 The follow-up visits were made at weeks 0, 4, 12, 20, 24, 36 and 52. Local ethics committees gave approval to the study protocol.
Clinical assessments Clinical assessments included tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate, C-reactive protein and morning stiffness duration. Patient-reported outcomes included global assessments of pain and general health on 100 mm visual analogue scales and HAQ disability index.10 11 Workability was evaluated as described in a previous paper.12 Data on comorbidities were collected from the clinical history of patients.
Study outcomes The primary outcome was disease remission after 12 months of follow-up, according to a very liberal therapeutic protocol (according to local decisions), although strict and tight in terms of assessment timing. For the evaluation of disease activity, we used two sets of criteria: DAS28 and the ACR criteria for clinical remission in RA.13 Disease activity according to DAS28 was interpreted as remission (DAS28 5.1) activity.
Treatment Therapy adjustments were protocolised to occur at every visit and, based on the DAS28 assessment, treatment was intensified if the predefined targets (ie, DAS28
